R&D Compliance and Quality made simple
Over the last 25 years, I’ve worked in in small, medium and large size companies holding senior leadership roles in companies like Takeda, Alexion and Shire.
The Compliance and Quality space found me (I didn’t look for it) about 10 years into my career, after working at the bench and selling and marketing scientific wares. It is not a topic taught as an undergraduate. Through my career I noted that people have very strong feelings about the Compliance and Quality areas. You either love it or hate it. You write an SOP or two, participate in an inspection or two and quickly determine your preference. For me, I love the compliance and quality space.Here’s why:
- The industry is patient-centric and a true patient-centric culture requires strong compliance program and high-quality outputs.
- Inspections with positive outcomes build confidence amongst management, the participants and health authorities (they do talk to each other).
- Compliance and quality can be simple. This usually gets a groan or an eye roll. It is not as laborious as you may think.
- Time is the most precious resource we have as human beings. With compliance and quality aspects infused from the start, rework and ‘fire fighting’ are avoided allowing for time for the important things like being on the soccer sidelines or the piano recital.
I learned early in my career that science is a business. I enjoy bringing together these areas and helping decision makers understand how business decisions impact regulatory compliance and how regulatory compliance supports the business. I have led multiple mergers where I harmonized operations and received accolades from health authorities on our positive outcomes. I have a laser sharp eye that quickly identifies complex processes across business functions. This helps me identify connections which immediately simplifies work.
With my business background, operations/lean six sigma mindset and quality and compliance experience, I am uniquely positioned to create solutions that meet the regulatory requirements and support the business culture. The end result delivers excellence, is effective and efficient.
My ultimate goal with everything I do is to “leave it better than I found it”. I hope to have the opportunity to discuss how this may work for you.
More about Jen
My favorite ice breaker is Two Truths and a Lie. It allows people to share fun facts or topics that they normally may not talk about in a work setting. My items are below. Let me know which one you think is not true, share your items or tell me what your favorite ice breaker is.
I’ve been skydiving
I despise peanut butter
I am 5′ 10″